A Follow-Up Volunteer Study Evaluating Intraosseous Vascular Access Infusion in the Sternum Using the EZ-IO T.A.L.O.N.Intraosseous System.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Occurrences of Extravasation During Infusion
研究概览
简要总结
This study is being done to evaluate intraosseous vascular access through the sternum.
详细描述
The purpose of this study is to evaluate the presence or absence of extravasation when using the T.A.L.O.N. Intraosseous System to establish sternal intraosseous infusion. This study will also evaluate the user preference feedback received from the device operators about the ease of use and level of satisfaction with the device. Lastly, this study will evaluate the infusion flow rates obtained when using intraosseous infusion in the sternum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •21 years of age or older;
- •healthy adult subjects
排除标准
- •Weight < 45kg;
- •BMI greater or equal to 30 with absence of adequate landmarks or too much overlaying tissue, as determined by the PI;
- •Imprisoned subjects;
- •pregnant subjects;
- •prior sternotomy;
- •cognitively impaired subjects;
- •fracture in target bone, or significant trauma to the site;
- •excessive tissue and/or absence of adequate anatomical landmarks in target bone;
- •infection in target area;
- •IO insertion in past 48 hours or other significant orthopedic procedure in target bone;
- •current use of anti-coagulants;
- •previous adverse reaction to Lidocaine;
- •current cardiac condition requiring pacemaker or anti-arrhythmic drugs
- •previous adverse reaction to contrast dye
- •Allergy to any food and drug
- •History of impaired renal function
- •History of impaired hepatic function
- •History of cardiac disease
- •History of pheochromocytoma
结局指标
主要结局
Occurrences of Extravasation During Infusion
时间窗: during 12 minutes of infusion
The number of participants with occurrence of extravasation during intraosseous infusion as evidenced by contrast injection into the intraosseous catheter, visualized under fluoroscopic imaging.
Occurrences of Extravasation During Infusion
时间窗: during 12 minutes of infusion
The number of participants with occurrence of extravasation during intraosseous infusion as evidenced by contrast injection into the intraosseous catheter, visualized under fluoroscopic imaging.
次要结局
- Adhesion Strips(During insertion of the intraosseous needle set)
- Gravity Flow Rates(during the 12 minute infusion time frame)
- Stability of Locator(During insertion of the intraosseous needle set)
- Stability of Catheter Hub(During insertion of the intraosseous needle set)
- Stability of Locator(During insertion of the intraosseous needle set)
- Adhesion Strips(During insertion of the intraosseous needle set)
- Stability of Catheter Hub(During insertion of the intraosseous needle set)
- Gravity Flow Rates(during the 12 minute infusion time frame)
- 100 Millimeters of Mercury (mmHg) Infusion Flow Rates(during the 12 minute infusion time frame)
- 200 Millimeters of Mercury (mmHg) Infusion Flow Rates(during the 12 minute infusion time frame)
- 300 Millimeters of Mercury (mmHg) Infusion Flow Rates(during the 12 minute infusion time frame)